# K061439: Aequalis Reversed Prosthesis

- Pathway: 510(k) (Special)
- Applicant: Tornier
- Decided: Jul 20, 2006 after 57 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K911686 (1991). 25 ancestors in all.
199 later devices descend from it; 10 cite it directly.
0 of 225 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030941: Aequalis Reversed Shoulder Prosthesis, Tornier (2004) Summary page 1.
- K041873: Aequalis Reversed Shoulder Prosthesis, Tornier (2004) Summary page 1.
- K050316: Aequalis Reversed Shoulder Prosthesis, Tornier (2005) Summary page 1.
- K952928: Aequalis Shoulder System for Total & Hemishoulder Applications, Tornier (1995) Summary page 1.
- K012212: Modification to Aequalis Shoulder System, Tornier (2001) Summary page 1.
- K041339: Aequalis Shoulder System, Tornier (2004) Summary page 1.
- K060209: Aequalis Shoulder Fracture System & Aequalis Shoulder System, Tornier (2006) Summary page 1.
- K021478: Delta Shoulder, Depuy, Inc. (2003) Summary page 1.

## Most influential descendants
- K081059: Aequalis Reversed Shoulder Prosthesis (2008), 179 descendants of its own
- K071948: Aequalis Reversed Adapter (2007), 178 descendants of its own
- K082120: Aequalis Reversed Fracture Shoulder Prothesis (2008), 164 descendants of its own
- K100142: Aequalis Reversed Shoulder Prosthesis (2010), 147 descendants of its own
- K110599: Aequalis Ascend Modular Reverse Shoulder System (2011), 108 descendants of its own

## Indications for use
The Aequalis Reversed Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation. When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis. When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to implant a base plate and a sphere of Aequalis Reversed range again, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

Source page: https://510kreport.com/device/K061439
Methodology: https://510kreport.com/methodology